news we can use on node pos and oncotype

cookiegal · December 2009

Additional data analyses presented at the CTRC-AACR San Antonio Breast Cancer Symposium today reinforced the conclusion that chemotherapy does not appear to benefit patients with either 1-3 or 4 or more positive nodes for disease-free survival over 10 years, if their tumors have a low Recurrence Score.

There was no breast cancer specific survival (BCSS) benefit from chemotherapy in either the low (log-rank p=0.56) or intermediate (log-rank p=0.89) Recurrence Score categories; however, chemotherapy resulted in superior BCSS in the high Recurrence Score category (log-rank p=0.033).

Could this be right?

As some of you know I am a low intermediate with one node, and I need to decide about chemo by next week.

I so hope this is not a mistake in press release writing! They have never said this for node negatives, that's what tailor x is for, so I am shocked they have figured this out for node pos.

cookiegal · December 2009

OK, I just got off the phone with genomic, one rep said he thought it might be wrong, another said the MD's are giving the report today, so it could be right.

Thanks!

flash · December 2009

I hope you'll use your fabulous sleuthing skills and let us know the final answer.

flash

cookiegal · December 2009

Thanks flash....fingers crossed.

I must say the oncotype people are very nice. They are in SF, and the guy I spoke to used to watch El Hubbo on the news.

He also said that I apparently broke the news to the call center!

OG56 · December 2009

Oh forever giving us the up to date news report, love it! I am keeping all my fingers and toes crossed for you! Let us know.

Big Gentle Hugs

Linda

Lauren3 · December 2009

Good luck!!!!

Gitane · December 2009

I got this from Abstract 112 "Prediction of 10-year chemotherapy benefit and breast cancer-specific survival by the 21-gene Recurrence Score (RS) assay in node-positive, ER-positive breast cancer --An update of SWOG-8814"

This isn't everything, just the stuff that I found very interesting.

We conducted a new DFS prediction analysis within nodal categories by RS over 10 years and assessed whether the assay has predictive utility for breast cancer specific survival (BCSS).

RT-PCR analysis for the RS assay were feasible in 148 patients on T and 219 patients on CAF followed by T.

For the exploratory analysis of BCSS, only deaths due to breast cancer were counted as events, censoring deaths due to other causes (such as late cardiovascular events) as well as patients alive at the last follow-up visit.

The 10-year estimates for BCSS for RS (with 95% confidence intervals) are

low RS 92% (79%-97%) for T 87% (76%-93%) for CAF+T

inter. RS 70% (50%-83%) for T 81% (67%-89%) for CAF+T

high RS 54% (38%-68%) for T 73% (60%-82%) for CAF+T

Conclusions: These additional exploratory analysis reinforce our initial interpretation that anthracycline-based chemotherapy does not appear to benefit patients with either 1-3 or 4 or more positive nodes over 10 years, if their tumors have a low RS.

cookiegal · December 2009

Thanks for posting that...hmmmmmm......from the looks of things it looks like intermediate gets a benefit...gosh not quite what I wanted to hear, but wow look at those numbers for low.

I am seeing my onc next week for the big talk. We shall see.

cookiegal · December 2009

gosh, I wish the oncotype folks would call back already!

I have no life I know, but I keep checking the press release to see if they correct it.

My grown-up self says this can not be right, it would be huge news.

I guess bad news for some who did chemo based on the score.

cookiegal · December 2009

shoot, went out to get hair and nails done and missed the call from oncotype. I spoke to someone else in the office who said for that study, the press release is correct.

I don't know how to justify this with the information Gitane put up from SWOG-8814...how those numbers translate to no benefit.

Paging Otter...or anyone else who is better with stats.

cookiegal · December 2009

Interesting

http://www.theglobeandmail.com/news/national/its-a-test-that-can-spare-women-from-chemo-but-they-cant-get-it-here/article1389937/

cookiegal · December 2009

Anyone figure this thing out?

merryheart · December 2009

As I am new I am unsure about what this would mean for me. Can you please help me to understand?

I am due to start TAC Chemo Jan 4th (and a CT Scan Dec 21st). Will this be encouraging for me given that 11 out of 17 nodes were positive (all nodes from right side) Will this give me a better survival rate? I am finding it difficult to get my head around all the info as well as trying to come to terms and deal with the stress/surgery etc. Any encouragement would be very very helpful. Thanks for your patience.

Merry

cookiegal · December 2009

Hi merry, I noticed you are probably triple negative. All this oncotype stuff does not apply to you. Typically, chemo is the treatment, and hormonals are not.

For ER positive, hormonals are key, chemo is an option for women with a lot of nodes or a higher onoctype recurrence score. Women with a low score often opt out of chemo. Those of us in the middle are left with a dillema.

We are hoping this new study gives us some more guidance.

Good luck with your treatment .

merryheart · December 2009

Thank you Cookiegal,

As it mentioned those with high numbers of positive nodes, I thought it meant me;, but you are saying that as I am not HR+ it doesn`t affect me?

Got a lot to learn.

Merry

Kathy044 · December 2009

Here are a few more quotes from the Lancet Oncology (full text) article (pub Dec 10th) being reported at the San Antonio Conference.(typos are mine).

Discussion: Our study suggests that patients with involved axillary lymph nodes, but a low recurrance score, do not seem to benefit from anthracycline-based chemotherapy, whereas those with a higher recurrence score have major benefit, independent of the number of positive nodes.

Our retrospective analysis included a subset of patients from SWOG-8814, although overall treatment effect and demographics were similar to those in the parent trial. In view of the low endpoint event rate, especially in the low recurrence score group, CIs were broad; therefore estimated benefit of CAF at specific recurrence score values should be interpreted with caution. Whereas there was no apparent benefit from CAF in patients with a low recurrence score for all endpoints, the possibility of benefit cannot be completely ruled out.

Prospective studies with larger sample sizes are essential to establish who benefits most from modern endocrine therapy plus chemotherapy, and whether use of multigene assays affects survival.

The abstract is available online here:

http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(09)70314-6/abstract

cookiegal · December 2009

thanks Kathy, anything about intermediates?

Have a great day!

Kathy044 · December 2009

Here's some numbers by the different scores cookiegal, the first column is for All years, the second the first five years, the third after 5 years. I'll just list the numbers for OS 18, 25, and 31 here.

Table 2: Disease-free survival hazard ratios...for chemotherapy benefit by recurrence score over time

18 . . . . 0.83(0.56-1.22) 1.03(0.58-1.81) 0.67(0.40-1.14)

25 . . . . 0.74(0.53-1.04) 0.87(0.53-1.42) 0.64(0.39-1.05)

31 . . . . 0.67(0.48-0.93) 0.75(0.48-1.18) 0.61(0.35-1.04)

This compares to the entire RS sample;

All........0.72(0.51-1.00) 0.79(0.51-1.23) 0.63(0.39-1.04)

which as I read this puts the benefit for all between the intermediate and high scores.

Hope this doesn't confuse things more than it matters. I'm still waffling over my decision, having that bone scan on Monday made me think a little bit closer about the possibility of cancer cells floating around waiting to spread. Why did the tech come over and ask me near the end if I had any fractures in the last five years or if I had any bone pain? Why the extra scans of my rib area? Perhaps my decision whether or not to do chemo has already been made for me.

Gitane · December 2009

Kathy, Thank you so much for posting this information. It's great!

Gitane · December 2009

Kathy, On a personal note, I really am bummed that the tech, with all the questions, has worried you so much. I have never had a bone scan, so I don't know why the questions or extra scans of the rib area. Seems like just being thorough, but that doesn't stop us from worrying. I hate that we have to make these important decisions with so little information or guidance. Somehow it seems like they should know more than they do, but there it is...HUGS!

cookiegal · December 2009

Ok.....sorry to be the slow one here...but I don't quite understand what tha hazard ration is

18 . . . . 0.83(0.56-1.22) 1.03(0.58-1.81) 0.67(0.40-1.14)

That being said, my ex boyfriend is an actuary and this is how he explained it

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

For every 100 people on T only, 70 will survive on average. Between 50
and 83 people will survive 95% of the time.

So, say you tested 100 groups of 100 people (i.e. 10000 in total). A
total of 7000 would survive. However, in five of those groups of 100,
fewer than 50 or more than 83 would survive.

As far as CAF + T, for every 100 people, 81 will survive on average.
Between 67 and 89 would survive 95% of the time.

The point is that although the CAF + T groups will be more successful
(i.e. have a greater survival rate) than the T only groups most of the
time, they won't be more successful all of the time. The gold standard
of statistical analysis is 95%. If one group is more successful than
another 95% of the time, it's considered to be more successful because
of some significant inherent quality. If not, there's considered to be
a reasonable chance that the greater success is just dumb luck.

I did some calculations, which I've attached. You need some stats
background to understand them, but if an actuary who is seventeen years
removed from his last stats class can handle this, so should an MD or
Ph.D. researcher. If I'm doing it right, what they show is that for the
intermediate RS group, CAF + T is more successful than T 86.1% of the
time for the intermediate cases and 97.2% for the high cases. So the
difference for high crosses the magic 95% threshold and is considered
significant, but the difference for intermediate is not considered
significant. However, if I were giving advice to someone I cared deeply
about, like a close relative or a former girlfriend who was always good
to me and who stayed a close friend, I'd think that 86.1% is nothing at
all to sneeze at, and say to go ahead and think very seriously about the
chemo.

They say they broke down the RS groups by nodal categories. But they
don't publish the differences between nodal categories within the RS
groups. Why (unless I need to read the whole paper to see that)?

cookiegal · December 2009

BTW he did spreadsheats for me, I can forward them to you if you pm me your email.

cookiegal · December 2009

OK so I just spoke with genomic, it was not as informative as I hoped for. The information released is not new perse, just how it effects treatment decisions.

So the statement about intermediate benefit was new to me, but not really new new.

She said basically, it is correct, that for that study, there is no bcssb for intermediate. The difference is that the confidence interval for low is much stronger than intermediate.

If you have a report, the info on the first two pages is based on b14 a study with node neg

the page three info is based on SWOG which was a study at Loyola that randomized 367 women in all ranges to chemo/no chemo.

so here is the deal, for 1-3 nodes the difference from b14 is small in distand recurrance rate

for 4 or more it's higher.

sigh

news we can use on node pos and oncotype

Comments

Categories